Clinical trial · Observational
A Prospective, Multicenter, Observational Cohort Study to Evaluate the Efficacy and Safety of a Novel Anti-tumor Drug as a Radiosensitizer in Patients With Advanced Breast Cancer Brain Metastasis.
NCT06839547CI-TRIAL-00114282recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A prospective, multicenter, observational cohort study to evaluate the efficacy and safety of a novel anti-tumor drug as a radiosensitizer in patients with advanced breast cancer brain metastasis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Breast Cancer Brain Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy + Novel Anti-tumor Drug | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Intracranial Progression-Free Survival
- timeFrame
- 24 months
- description
- The time from the randomization of the subject to the first documented tumor progression (PD) or death due to any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Males or females who are at least 18 years of age on the day of signing the informed consent form. 2. Patients with advanced breast cancer that is inoperable and has metastasized to the brain, confirmed by histology or cytology. 3. Patients who are planned to receive, currently receiving, or have completed intracranial radiotherapy after discussion by a multidisciplinary team (MDT) at the stage of brain metastasis. 4. Patients who are planned or currently receiving a systemic treatment regimen with a novel anti-tumor drug selected by the physician, within 3 weeks before radiotherapy, during radiotherapy, or within 3 weeks after completion of radiotherapy. These drugs include: ADC drugs (such as T-DXd, T-DM1, etc.), CDK4/6 inhibitors, TKI drugs (such as Pyrotinib, Tucatinib, etc.), Novel chemotherapy drugs (such as Utidelone, Irinotecan liposomes, etc.), Bevacizumab, PD-1/PD-L1 inhibitors, etc. 5. Patients with a traceable medical history during the treatment period. 6. Patients who are able to sign the informed consent form to participate in the study. Exclusion Criteria: 1. The subject has leptomeningeal metastasis. 2. If the patient has concurrent brain metastasis, the neurological symptoms are too severe to cooperate with radiotherapy. 3. The subject has not signed the informed consent form. 4. Pregnant or breastfeeding women. 5. Other situations deemed by the investigator as unsuitable for inclusion in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.